Edesa Biotech Publishes Phase 2 Substudy Results of ARDS Drug Candidate

• Company's host-directed therapeutic, EB05 (paridiprubart), demonstrated a statistically significant mortality reduction among critically ill patients with severe respiratory disease

TORONTO, ON / ACCESSWIRE / September 28, 2023 / Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, announced the preprint publication of favorable data from a Phase 2 substudy of critically ill patients with a severe form of respiratory disease called Acute Respiratory Distress Syndrome (ARDS). Approximately 10% of all intensive care admissions are ARDS related.

The formal manuscript available today in preprint consists, in part, of mortality rates from critically ill patients who received mechanical ventilation plus additional organ support, including extracorporeal membrane oxygenation (ECMO) therapy, and who were hospitalized for SARS-CoV2-related respiratory disease during the pandemic. Among the findings, a survival analysis using Cox's Proportional Hazard Model demonstrated that patients treated with EB05 (paridiprubart) plus standard of care had an 84% reduction in the risk of dying when compared to placebo plus standard of care at 28 days. Edesa previously released summarized study results and the preprint manuscript is the first-time that the detailed data is available with supporting tables, listings, figures and references.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said the data demonstrate a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill substudy. "We believe these promising results in one of the most difficult-to-treat populations are encouraging as we explore the therapy's broader potential utility."

Paridiprubart represents a new class of emerging therapies called Host-Directed Therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with infectious diseases or even chemical agents. Importantly, these therapies are designed to work across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks. Because they are threat agnostic, HDTs like paridiprubart have the potential to become standard of care in ICUs and critical countermeasures for both pandemic preparedness and biodefense.

Based in part on these data, the company initiated a Phase 3 study, and has received a Fast Track designation from the U.S. Food and Drug Administration.

A preprint manuscript, titled "A Phase 2, randomized, double-blind, placebo-controlled multi-center trial sub-study for the clinical effects of paridiprubart treatment in hospitalized critically ill patients with COVID-19 ARDS," is published on medRxiv at https://www.medrxiv.org/content/10.1101/2023.09.21.23295853v1

About ARDS

ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to Covid-19, ARDS accounted for 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About EB05 (paridiprubart)

Paridiprubart is a first-in-class monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. This host-directed therapeutic (HDT) candidate inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated both by viruses, like SARS-CoV2, SARS-CoV1 and Influenza, as well as in the pathogenesis of chronic autoimmune diseases.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (NASDAQ:EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. The company's most advanced drug candidate is EB05 (paridiprubart), a monoclonal antibody developed for acute and chronic disease indications that involve dysregulated innate immune responses. Edesa is currently evaluating EB05 in a Phase 3 study as a potential treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure. In addition, Edesa is developing an sPLA2 inhibitor, EB01 (daniluromer), as a topical treatment for chronic Allergic Contact Dermatitis (ACD), a common occupational skin condition. The company has also received regulatory approval to conduct a Phase 2 trial of its EB06 monoclonal antibody as a treatment for vitiligo, a life-altering autoimmune disease that causes skin to lose its color in patches. Edesa is also planning to file an investigational new drug application for a future Phase 2 study of paridiprubart for systemic sclerosis (scleroderma), an autoimmune rheumatic disorder that causes fibrosis, (scarring/hardening) of skin and internal organs such as the lungs, heart and kidneys. Sign up for news alerts. Connect with us on Twitter and LinkedIn.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company's belief that the data demonstrate a statistically significant and clinically meaningful trend for mortality and survival time for all randomized subjects in the critically ill substudy; the company's belief that these results are favorable, and that such results in a difficult-to-treat population are encouraging; the company's plans to advance the Phase 3 clinical study for EB05 and explore the therapy's broader potential utility; the company's belief that paridiprubart represents a new class of Host-Directed Therapeutics (HDTs) that may provide utility across multiple infectious diseases and threats, and could be stockpiled preemptively ahead of outbreaks; the company's view that paridiprubart could provide a safe and effective treatment for ARDS caused by coronaviruses, pandemic influenza and harmful bacteria; the company's belief that HDTs like paridiprubart have the potential to become standard of care in ICUs and critical countermeasures for both pandemic preparedness and biodefense; and plans and timelines regarding the company's clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as Covid-19. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contact
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800
investors@edesabiotech.com

SOURCE: Edesa Biotech